PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
FDA premarket approval P900052/S014 · decided 2007-08-28
Approval details
- PMA number
- P900052
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2006-12-08
- Decision date
- 2007-08-28
- Days to decision
- 263 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS. THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB. 2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL A
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